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Clinical Trials/NCT04269863
NCT04269863
Unknown
Not Applicable

Personalizing Antiplatelet Therapy in Peripheral Arterial Disease Patients

Unity Health Toronto0 sites150 target enrollmentNovember 1, 2020
InterventionsAspirin
DrugsAspirin

Overview

Phase
Not Applicable
Intervention
Aspirin
Conditions
Peripheral Arterial Disease
Sponsor
Unity Health Toronto
Enrollment
150
Primary Endpoint
PAD disease progression
Last Updated
5 years ago

Overview

Brief Summary

Antiplatelet therapies are important to decrease the morbidity and mortality associated with Peripheral Arterial Disease (PAD) through the prevention of thrombus formation. Aspirin (ASA) is a readily available and affordable antiplatelet medication that can help reduce adverse cardiovascular events by up to 25%. However, 25-60% of PAD patients are "ASA insensitive" having a lower than normal ability to inhibit platelet aggregation after standard aspirin dosing. In a previous study conducted by our lab, we were able to demonstrate a methodology for personalizing antiplatelet therapy using two platelet function tests, Platelet Function Analyzer-100 (PFA 100) and Light Transmission Aggregometry (LTA). To investigate this methodology further, we would like to conduct a pilot study on two cohorts of patients, one population continuing with their current medications (81mg ASA), and a second group who will get personalized antiplatelet therapy using our methodology (81-325mg ASA). In this study, 150 PAD patients taking 81mg Aspirin therapy presenting for clinical follow-up, or in-patient intervention, in vascular clinics or the emergency room, will be recruited to our study. 75 patients will be randomly assigned undergo platelet analysis using PFA-200 and LTA, and will have their antiplatelet therapy personalized. Patients will then be followed up in order to see if the patients with personalized therapy have better platelet inhibition. This study will allow us to help personalize antiplatelet therapy in PAD patients, allowing for better patient outcomes and decreased adverse cardiovascular events.

Registry
clinicaltrials.gov
Start Date
November 1, 2020
End Date
November 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohammad

Vascular Surgeon

Unity Health Toronto

Eligibility Criteria

Inclusion Criteria

  • Self-reported intake of either 81 mg of aspirin per day for 3 or more days
  • Diagnosed with peripheral arterial disease

Exclusion Criteria

  • Alcohol ingestion 24 hours prior to blood draw
  • Patients receiving glycoprotein (GP) IIb/IIIa antagonists
  • Ingestion of a non steroidal anti-inflammatory drug 3 days prior to blood draw
  • History of bleeding disorders
  • Gastrointestinal bleeding
  • Hemorrhagic stroke
  • Allergy to aspirin or ticagrelor
  • Pregnancy, thrombocytopenia anmia or leukopenia

Arms & Interventions

Control Group

This group of 75 patients is the control group that will be receiving the standard lowest dosage of 81mg aspirin.

Intervention: Aspirin

Treatment Group

This group of 75 participants is the treatment group that will be receiving personalized aspirin dosage between 81mg-325mg (within standard clinical recommendations), which will be determined based on platelet analysis via PFA-200.

Intervention: Aspirin

Outcomes

Primary Outcomes

PAD disease progression

Time Frame: 1 year

Using lower limb arterial imaging (doppler ultra sound), and ankle brachial index, patients will be categorized based on Ruthorford Classification of chronic limb ischemia. Progression of PAD will be considered decrease in ABI, and progression to more sever forms according to the Rutherford classification.

development of Critical limb ischemia

Time Frame: 1 year

Critical limb ischemia will considered as those patients who have progressed from claudication to night paint, rest pain, and/or tissue loss.

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